WRAP-IT trial summary
WRAP-IT trial is a multicenter, randomized, controlled, prospective, single-blind trial that was published in the New England Journal of medicine in 2019. The objective of the WRAP-IT trial was to assess the safety and efficacy of an absorbable, antibiotic-eluting envelope in reducing the incidence of infection associated with cardiac implantable electronic devices (CIED) implantations.
The study population of the WRAP-IT trial included 6,983 patients undergoing CIED generator replacement or a system upgrade with or without new leads, those undergoing CIED pocket or lead revision, and those undergoing an initial CRT-D procedure were randomized to receive CEID envelope (3,495) or to control group (3,488).
The primary outcome of infection, long-term antibiotic therapy with infection recurrence, or death, within 12 months occurred in 0.7% of patients who received CEID compared to 1.2% in the control group (HR 0.60; 95% CI, 0.36 to 0.98; P=0.04).
The authors of the WRAP-IT trial concluded that adjunctive use of an antibacterial envelope significantly lowers the incidence of major CIED infections versus standard-of-care infection prevention strategies alone, without a higher incidence of complications.
- The study showed 40% reduction in major infections
- The envelope was successfully implanted in 99.7% of procedure attempts, and the safety objective was met
- The authors observed 61% fewer deep incisional pocket infections in the envelop group.
- Note: The PADIT trial compared the antibiotics strategy for preventing device infections.